FDA Targets Clinics Offering Unapproved Stem Cell Therapies

The FDA notes that some patients have experienced "serious and permanent harm" after undergoing unapproved stem cell therapies.

HealthDay News — The U.S. Food and Drug Administration has launched legal action to stop two stem cell clinics from providing unapproved treatments that have caused serious, long-term harm to some patients.

On Wednesday, the FDA filed complaints in federal court seeking permanent injunctions against U.S. Stem Cell Clinic LLC of Sunrise, Fla., and California Stem Cell Treatment Center Inc./Cell Surgical Network Corporation and their executives. Along with marketing unapproved stem cell treatments, inspections of the clinics revealed improper manufacturing practices, which could affect the sterility of their products and put patients at risk, the FDA said.

"Cell-based regenerative medicine holds significant medical opportunity, but we've also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients' health at risk," FDA Commissioner Scott Gottlieb, M.D., said in an agency news release. "In some instances, patients have suffered serious and permanent harm after receiving these unapproved products."

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